QA & Regulatory Compliance Specialist (GxP, GMP/GLP/GCP)

Tekprosol; Princeton (NJ); Híbrido; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Tekprosol in Princeton, NJ, seeks a Quality Assurance Specialist to provide QA and regulatory support across pharma, biotech and CROs, ensuring GxP compliance in GMP, GLP, GCP, GDP environments.

The role includes internal audits, CAPA oversight, and eTMF audit responses, with exposure to viral vector processes, aseptic operations, and complex cell-based systems. Travel across the U.S. may be required.

Formación

• Master's degree required in Science, Technology, Business Administration, or Engineering.
• Experience in Pharmaceutical, Biotech, and CRO industries with GxP compliance.
• Audit management, CAPA oversight, and eTMF audit responses.

Responsabilidades

• Provide QA and regulatory support across Pharmaceutical, Biotech and CRO industries.
• Ensure compliance with GxP (GMP, GLP, GCP, GDP) regulations.
• Manage internal audits, CAPA oversight, and eTMF audit responses.
• Develop and monitor data-driven quality metrics and improvements.

Conocimientos

Quality Assurance Specialist

Educación

Master's degree (Science/Technology/Business/Engineering)

Descripción del empleo

Tekprosol in Princeton, NJ, seeks a Quality Assurance Specialist to provide QA and regulatory support across pharma, biotech and CROs, ensuring GxP compliance in GMP, GLP, GCP, GDP environments.

The role includes internal audits, CAPA oversight, and eTMF audit responses, with exposure to viral vector processes, aseptic operations, and complex cell-based systems. Travel across the U.S. may be required.